A study to evaluate the safety and equivalence of serum phosphate control of a new sevelamer carbonate tablet formulation in comparison with Renvela® in chronic kidney disease patients on hemodialysis

• Conditions: Evaluation of the safety and equivalence of serum phosphate control of asevelamer carbonate tablet formulation in comparison withRenvela® in chronic kidney disease patients on hemodialysis; MedDRA version: 14.1Level: LLTClassification code 10020712Term: HyperphosphatemiaSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2011-006320-20-BG
• Lead Sponsor: Synthon BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-19
• Last Update Posted: 4 February 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

[1] Male and female Caucasian patients aged =18 years. Women of childbearing potential must have a
negative serum pregnancy test immediately prior to study entry, and meet the criteria for acceptable birth control (see paragraph 8.2), or female patients must be either post-menopausal for =1 year or surgically sterilised
[2] Stable maintenance hemodialysis regarding frequency (2 or 3 times per week) and dialysis parameters (e.g. average duration, type of dialyzer) for at least 3 months
[3] Life expectancy of at least 12 months
[4] At screening for patients not receiving previous treatment with phosphate binders or after 2 weeks
wash-out for patients who had previous therapy with phosphate binders: Serum phosphorus =1.78 mmol/l (=5.5 mg/dl)
[5] Intact parathyroid hormone (iPTH) =87 pmol/l (=800 pg/ml)
[6] Patients on stable diet and willing to follow stable diet
[7] Patients with ability to follow study instructions and likely to attend and complete all required visits
[8] Written informed consent of the patient.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

[1] Hypersensitivity to sevelamer or to any of the excipients of the study drugs
[2] Poorly controlled diabetes mellitus (HbA1c >11%)
[3] Poorly controlled hypertension (blood pressure higher than 150/90 mm Hg)
[4] Iron overload: serum ferritin >800 ng/ml combined with TSAT >50%
[5] Swallowing disorder (dysphagia)
[6] Bowel obstruction
[7] Gastrointestinal motility disorders including:
- untreated or severe gastroparesis,
- diverticulosis,
- retention of gastric contents, or
- abnormal or irregular bowel motion.
[8] Active inflammatory bowel disease
[9] History of clinically relevant gastrointestinal surgery (excluding minor surgery, such as uncomplicated appendectomy, polypectomy or non-intestinal tract abdominal surgery, such as cholecystectomy)
[10] Severe vomiting
[11] Severe constipation
[12] Concomitant malignancy (except carcinoma in situ not needing other than local therapy and basal cell carcinoma of the skin)
[13] Use of:
- antacids,
- drugs that affect gastrointestinal motility,
- ciprofloxacin, (unless this medicinal product is administered at least one hour before or 3 hours after
sevelamer)
- phosphate binders containing aluminium, magnesium, calcium or lanthanum for the duration of
the study. A calcium supplement is acceptable if the dose remains unchanged between randomization
and completion of the study,
- levothyroxine,
- anti-arrhythmic medication,
- anti-seizure medication.
[14] Active vasculitis
[15] Alcohol /drug dependence or abuse (excluding tobacco abuse)
[16] Pregnancy or lactation
[17] Women of childbearing potential unable or unwilling to practice adequate contraceptive measures
[18] Positive serologic findings for human immunodeficiency virus (HIV) antibodies
[19] Simultaneous participation in another clinical study or participation in any clinical study involving an investigational drug within 1 month prior to start of the present study
[20] Severe physical or mental concomitant diseases that might hamper the realisation of the trial according to protocol
[21] Legal incapacity and/or other circumstances rendering the patient unable to understand the
nature, scope and possible consequences of the study
[22] Unreliability or lack of cooperation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified